Precision Medicine for Patients With Identified Actionable Mutations
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Lymphoma
- Malignant Neoplasm
- Multiple Myeloma
- Mutation Abnormality
- Solid Tumor
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Primary Objective: • To estimate the progression-free ratio, as defined by the progression-free survival time on study treatment divided by the progression-free survival time on the last treatment received by patient, for an identified actionable mutation, who will be treated with an off-label treat...
Primary Objective: • To estimate the progression-free ratio, as defined by the progression-free survival time on study treatment divided by the progression-free survival time on the last treatment received by patient, for an identified actionable mutation, who will be treated with an off-label treatment off label therapy based on a simplified selection methodology using the Next Generation Sequencing results. Secondary Objectives: To estimate patient response rate on off-label treatments for actionable mutations based on Next Generation Sequencing results. To estimate overall survival (OS) for patients treated with off-label treatments for actionable mutations based on Next Generation Sequencing results. To describe the safety of using off-label or other experimental treatments for patients with actionable mutations based on Next Generation Sequencing results. Exploratory Objectives: To describe health related quality of life in patients undergoing off-label treatment targeting genetic mutations, as measured by the PROMIS-29 Overall Health-Related Quality of Life, Including 4-Item Anxiety Subscale. Using the Satisfaction with Medical Decision Scale, to describe patient satisfaction with decision to pursue off-label treatment. To identify types of actionable mutations with available targeted treatment occurring in cancer patients. To characterize the historical treatment regimens for these patients relative to the targetable mutation. To describe patient clinical and demographic characteristics of those with actionable mutations based on Next Generation Sequencing results. To identify barriers to treatment based on Next Generation Sequencing results.
Tracking Information
- NCT #
- NCT04111107
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Stefan Grant, MD Wake Forest University Health Sciences